301144389 v2
exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE OF INFORMATION THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
COLLABORATION, OPTION and License Agreement
This Collaboration, Option and License Agreement (the “Agreement”), effective as of March 5, 2024 (the “Effective Date”), is made by and between:
Merus N.V., a corporation organized and existing under the laws of the Netherlands having a place of business at Uppsalalaan 17, 3584 CT Utrecht, The Netherlands (“Merus”), and
Gilead Sciences, Inc., a Delaware corporation having a place of business at 333 Lakeside Drive, Foster City, CA 94404, USA (“Gilead”).
Merus and Gilead are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
RECITALS
Whereas, Merus is a biotechnology company engaged in the research and development of multi-specific antibody therapeutics in immuno-oncology;
Whereas, Gilead is a biopharmaceutical company that researches, develops, manufactures and commercializes therapeutic products, including in oncology indications;
Whereas, Merus and Gilead desire to collaborate on the use of Merus’s proprietary antibody platform to develop certain multi-specific antibody products for the treatment of certain indications, including oncological malignancies;
Now, Therefore, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, Merus and Gilead hereby agree as follows:
DEFINITIONS
301144389 v2
2
301144389 v2
3
301144389 v2
4
301144389 v2
5
301144389 v2
“Gilead IP” means, on a Program-by-Program basis, any Know-How or Patent Controlled by Gilead or its Affiliates as of the Effective Date or at any time during the Collaboration Period that is [***]
6
301144389 v2
7
301144389 v2
8
301144389 v2
All aforementioned deductions shall [***] and shall be determined, [***], [***], in accordance with [***]. [***]. In no event shall any particular amount identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of deductions). Net Sales shall not include sales between or among Gilead, its Affiliates, or Sublicensees, but shall include the subsequent re-sales to a Third Party; provided that Net Sales shall be determined on, and only on, the first sale by Gilead or any of its Affiliates or Sublicensees to a non-Sublicensee Third Party.
Net Sales shall not include [***], to the extent provided [***], but shall include [***].
If a Product is sold in any country or other jurisdiction in the form of a Combination Product, then the Net Sales for such Combination Product in such country or other jurisdiction shall be calculated as follows:
9
301144389 v2
10
301144389 v2
11
301144389 v2
12
301144389 v2
13
301144389 v2
GOVERNANCE
14
301144389 v2
15
301144389 v2
16
301144389 v2
DISCOVERY AND RESEARCH COLLABORATION
17
301144389 v2
18
301144389 v2
19
301144389 v2
20
301144389 v2
LICENSES; OPTION
21
301144389 v2
22
301144389 v2
23
301144389 v2
24
301144389 v2
DEVELOPMENT AND COMMERCIALIZATION
25
301144389 v2
26
301144389 v2
FINANCIAL TERMS
27
301144389 v2
Development Milestone Event | Milestone Payment | ||
Program #1 | Program #2 | Program #3 | |
1) [***] | [***] | [***] | [***] |
2) [***] | [***] | [***] | [***] |
3) [***] | [***] | [***] | [***] |
4) [***] | [***] | [***] | [***] |
5) [***] | [***] | [***] | [***] |
6) [***] | [***] | [***] | [***] |
7) [***] | [***] | [***] | [***] |
8) [***] | [***] | [***] | [***] |
9) [***] | [***] | [***] | [***] |
10) [***] | [***] | [***] | [***] |
11) [***] | [***] | [***] | [***] |
12) [***] | [***] | [***] | [***] |
Total | [***] | [***] | [***] |
28
301144389 v2
Commercial Milestone Event | Milestone Payment | ||
Program #1 | Program #2 | Program #3 | |
1) [***] | [***] | [***] | [***] |
2) [***] | [***] | [***] | [***] |
29
301144389 v2
3) [***] | [***] | [***] | [***] |
4) [***] | [***] | [***] | [***] |
Total | [***] | [***] | [***] |
For that portion of annual Worldwide Net Sales of all Products arising from such Program | Royalty Rate | ||
Program #1 | Program #2 | Program #3 | |
1) [***] | [***] | [***] | [***] |
2) [***] | [***] | [***] | [***] |
3) [***] | [***] | [***] | [***] |
4) [***] | [***] | [***] | [***] |
30
301144389 v2
31
301144389 v2
32
301144389 v2
33
301144389 v2
INTELLECTUAL PROPERTY
34
301144389 v2
35
301144389 v2
Prior to License Option Effective Date. Prior to the License Option Effective Date, on a Program-by-Program basis, Merus shall have the first right to control the Prosecution and Maintenance of [***] conceived, discovered, developed or otherwise made under this Agreement on a worldwide basis, at Merus’s sole cost and expense. [***]. Merus shall keep Gilead reasonably informed with respect to the Prosecution and Maintenance of such [***], [***]. Without limiting the foregoing Merus shall [***]. If, prior to the License Option Effective Date, Merus decides that it no longer wishes to continue the Prosecution and Maintenance of a particular [***], then it will promptly provide written notice to Gilead of such decision (in any case at least [***] prior to the next deadline for any action that may be taken with respect to such [***] in such country or other jurisdiction). Gilead may, upon written notice to Merus, assume the Prosecution and Maintenance of such [***], at Gilead’s sole cost and expense. [***].
36
301144389 v2
37
301144389 v2
38
301144389 v2
39
301144389 v2
40
301144389 v2
7.10 Joint Patent Committee.
Upon Gilead’s request, Merus and Gilead will form a joint patent committee (the “JPC”) to provide oversight and to facilitate information sharing between the Parties with respect to the Prosecution and Maintenance and enforcement of [***] as provided hereunder. The JPC will be comprised of [***] representatives of each Party, with each representative having knowledge and expertise in Patent portfolio management and licensing matters. Each Party may replace any of its JPC representatives at any time upon written notice to the other Party, which notice may be given by e-mail. Promptly after the Effective Date, the Parties shall negotiate a community of interest agreement to permit the sharing of information protected under applicable doctrines of privilege and confidentiality. Each JPC representative will be subject to confidentiality obligations no less stringent than those set forth in Article 8 and those privileges and confidentiality subject to the community of interest agreement. The JPC shall continue to exist [***] or such earlier date as may be established by mutual agreement of the Parties.
41
301144389 v2
CONFIDENTIALITY
42
301144389 v2
43
301144389 v2
44
301144389 v2
45
301144389 v2
46
301144389 v2
47
301144389 v2
REPRESENTATIONS AND WARRANTIES
48
301144389 v2
49
301144389 v2
50
301144389 v2
INDEMNITY; INSURANCE
51
301144389 v2
52
301144389 v2
All insurance programs required to be maintained hereunder shall be [***]. To the extent requested by the other Party, each Party shall provide the other with an original certificate of insurance evidencing that (i) all such insurance coverages are in effect, and (ii) none of the required policies of insurance shall be terminated or cancelled by insurers except upon at least [***] written notice to the other Party. Nothing contained in this Section 10.3 is intended to shall be construed, to limit either Party’s indemnity obligations under this Agreement.
TERM; TERMINATION
53
301144389 v2
54
301144389 v2
Termination for Patent Challenge. Except to the extent the following is unenforceable under the laws of a particular jurisdiction, Merus shall have the right to terminate this Agreement in its entirety if Gilead or its Affiliates or Sublicensees, directly or indirectly, individually or in association with any other Person, commences a legal action challenging the validity, enforceability or scope of any Merus Patents anywhere in the world (“Patent Challenge”), and Gilead or its applicable Affiliates or Sublicensees do not withdraw such Patent Challenge within [***] after Merus provides written notice to Gilead of such Patent Challenge. For clarity, the foregoing right of termination shall not apply with respect to any Patent Challenge where the Patent Challenge is [***]; [***]. For clarity, [***].
55
301144389 v2
56
301144389 v2
DISPUTE RESOLUTION
57
301144389 v2
58
301144389 v2
MISCELLANEOUS
59
301144389 v2
60
301144389 v2
61
301144389 v2
If to Merus, addressed to: Merus N.V.
Uppsalalaan, 3584 CT Utrecht
The Netherlands
Attention: Chief Operating Officer and General Counsel Peter Silverman
Email: [ ]
With copy to: [ ]
With a copy to: Cooley LLP
3175 Hanover St.
Palo Alto, CA 94304
Attention: [ ]
Email: [ ]
If to Gilead, addressed to: Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
USA
Attention: VP, Alliance Management
Email: [ ]
With a copy to: Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
United States
Attention: General Counsel
Email: [ ]
62
301144389 v2
63
301144389 v2
{Signature Page Follows}
64
301144389 v2
IN WITNESS WHEREOF, the Parties have caused this Collaboration, Option and License Agreement to be duly executed by their authorized representatives as of the Effective Date.
Merus N.V.
By: /s/ Bill Lundberg
Name: Sven (Bill) Ante Lundberg, M.D.
Title: President and Chief Executive Officer
{Signature Page to Collaboration, Option and License Agreement}
301144389 v2
IN WITNESS WHEREOF, the Parties have caused this Collaboration, Option and License Agreement to be duly executed by their authorized representatives as of the Effective Date.
Gilead Sciences, Inc.
By:/s/ Andrew Dickinson
Name: Andrew Dickinson
Title: Chief Financial Officer
{Signature Page to Collaboration, Option and License Agreement}
301144389 v2
List of Schedules and Exhibits
Schedule 1.74: Merus Platform Patents
Schedule 1.102 Program #1 Targets
Schedule 3.3: Initial Research Plans
Schedule 6.8: [***]
Schedule 7.3 P&M Notice Patents
Schedule 8.7: Joint Press Release
Schedule 9.2(d): Existing Patents
301144389 v2
Schedule 6.8
[***]
[***]: